Beginning Jan. 1, 2026, China will apply provisional import tariff rates lower than the most-favored-nation rates on 935 items, the State Council announced. The move aims to boost collaboration between domestic and international sectors, and to leverage resources of both to expand the supply of high-quality goods.
Askbio Inc., a subsidiary of Bayer AG, has received IND clearance from the FDA for AB-1009, an AAV gene therapy being developed for the treatment of late-onset Pompe disease.
A2 Biotherapeutics Inc. has gained IND clearance from the FDA for A2B-543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced or metastatic solid tumors.
Debate over Vanda Pharmaceuticals Inc.’s Hetlioz (tasimelteon) for use in jet lag disorder looks to continue after the U.S. FDA rejected the latest supplemental NDA submission, with the agency’s Center for Drug Evaluation and Research concluding the application cannot be approved in its current form.
Hutchmed Ltd. plans to file a second NDA in China for sovleplenib, a novel spleen tyrosine kinase inhibitor, based on positive phase II/III findings in warm antibody autoimmune hemolytic anemia.
The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of wearables that make modest claims regarding health, but anyone who was expecting a clear break with the 2019 version of the guidance was almost certainly disappointed.
In a big week for W.L. Gore & Associates Inc., the company reported plans to acquire Conformal Medical Inc. and received U.S. FDA approval for its Viabahn Fortegra venous stent for use in the inferior vena cava, iliac and iliofemoral veins.
It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.
Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.
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